Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT06869018
Eligibility Criteria:
Inclusion Criteria:
Part A:
* Participants with T2DM for at least 6 months
* With an HbA1c value:
* equal to or greater than 7.0% and equal to or less than 10.0% at screening for participants treated with diet and exercise alone, OR
* equal to or greater than 6.5% and equal to or less than 9.0% for participants prior to washout of antidiabetic medications
* Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5% body weight change
Part B:
* Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Laboratory tests may be repeated if there is a documented technical error, or once at the discretion of the investigator for any out-of-range results
Exclusion Criteria:
* Have a known clinically significant gastric emptying abnormality
* Have a 12-lead electrocardiogram (ECG) abnormality
* Have an abnormal blood pressure or pulse rate
* Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drug. Or constituting a risk when taking the study drug
* Have a history of chronic medical conditions involving the heart, liver, or kidneys
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06869018
Study Brief:
Protocol Section:
NCT06869018